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Mitroflow heart valve: 5.5 years clinical experience.
J M Revuelta1, J M Bernal, J A Gutierrez
1Hospital N. Marqués de Valdecilla, University of Cantabria, Santander, Spain.
The Thoracic and Cardiovascular Surgeon
|October 1, 1988
Summary
The Mitroflow pericardial heart valve showed satisfactory medium-term performance, but early mitral valve failures were noted. This study evaluated 139 valves in 129 patients, focusing on clinical outcomes and complications.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Clinical Outcomes Research
Background:
- The Mitroflow pericardial heart valve was used in cardiac valve replacement surgeries.
- Understanding its long-term clinical performance is crucial for patient care and device development.
Purpose of the Study:
- To evaluate the clinical performance and complications of the Mitroflow pericardial heart valve.
- To assess survival rates, thromboembolism, and tissue failure in patients receiving the valve.
Main Methods:
- A retrospective review of 139 Mitroflow valves implanted in 129 patients between March 1982 and December 1986.
- Follow-up data was collected for up to 5.5 years, totaling 407.25 patient-years.
- Outcomes analyzed included mortality, thromboembolism, prosthetic endocarditis, tissue failure, and reoperation rates.
Main Results:
- Overall hospital mortality was 1.6%, with a linearized late mortality of 0.49% per patient-year. Actuarial survival was 96%.
- Thromboembolism incidence was 1.22% per patient-year, with a 93% freedom rate. Prosthetic endocarditis occurred in one patient.
- Three cases of primary tissue failure were observed in the mitral position, with a linearized incidence of 0.73% per patient-year. Reoperation was required in 4 patients.
Conclusions:
- The Mitroflow pericardial heart valve demonstrates satisfactory medium-term clinical performance.
- However, a significant rate of early primary tissue failure in the mitral position warrants attention and further investigation.